Senior Director, Global Bioanalysis – DMPK

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Oversee the global bioanalytical function while managing both internal and external resources.

• Provide strategic direction and functional leadership for bioanalytical and biomarker initiatives throughout discovery, translational, preclinical, and clinical development programs.

• Create and implement biomarker strategies to align with research goals and development decisions.

• Manage, mentor, and develop direct reports through setting objectives, performance reviews, career progression, succession planning, and scientific guidance.

• Lead efforts in recruitment, onboarding, and retention.

• Cultivate a collaborative team culture among geographically diverse employees, contractors, and external partners.

• Supervise functional budgets, forecasting, resource allocation, vendor/CRO expenditure management, and financial oversight.

• Represent bioanalysis in discussions and project teams across various functional leadership areas.

• Collaborate with Discovery, Translational Sciences, Toxicology, PK, Clinical Pharmacology, Regulatory Affairs, and Clinical Development teams globally.

• Establish and maintain relationships with global CROs, laboratories, and external vendors.

• Oversee the selection, governance, performance management, and resolution of issues with CROs.

• Manage CROs for method transfer, qualification/validation, sample analysis, and data assessment.

• Review statements of work to ensure alignment with project goals.

• Analyze and interpret bioanalytical data effectively.

• Author and review study plans, method development summaries, validation reports, and sections for regulatory submissions, including INDs and NDAs.

• Track deliverables and communicate updates, risks, and recommendations.

• Ensure adherence to GLP, GCP, and global regulatory standards.

• Write and maintain SOPs while documenting scientific and operational decisions.

• Contribute to studies involving metabolite profiling and identification.

• Support global development programs across various regions and time zones.

• Travel approximately 10%-20% to CROs and external partners.

⛳️ Requirements

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field.

• At least 15 years of experience in biotechnology, pharmaceutical, or CRO settings, demonstrating increasing leadership responsibilities.

• Proven experience in leading, developing, and managing scientific teams and direct reports.

• Experience in supporting bioanalytical and biomarker programs throughout discovery, translational, preclinical, and clinical development phases.

• Expertise in managing global CROs and supervising external assay transfers, validation processes, and strategic outsourcing partnerships.

• Experience collaborating with international vendors and external partners across the US, UK, and EU.

• Proficient in assay sensitivity, selectivity, reproducibility, and data interpretation.

• Hands-on experience in quantitative LC-MS/MS method development and validation for small molecule drug development.

• Proficient with LC-MS/MS instrumentation, including Sciex, Waters, or Thermo, and related software platforms such as Analyst, MassLynx, or Xcalibur.

• Knowledgeable about global regulatory bioanalytical standards and guidelines, including FDA, EMA, ICH M10, and GLP/GCP environments.

• Experience in supporting Toxicology, Pharmacokinetics, and Clinical Pharmacology programs throughout drug development.

• Familiarity with supporting IND-enabling studies and clinical-stage development programs.

• Ability to influence and collaborate effectively within a matrixed global organization.

• Excellent written, verbal, and interpersonal communication skills.

• Strong project management, organizational, and stakeholder management abilities.

🏝️ Benefits

• Company bonus based on both company and individual performance.

• Company-sponsored 401(k).

• Pension plan.

• Vacation benefits.

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, including employee assistance programs, fitness benefits, and employee clubs and activities.

• Remote work arrangements available.